{"id":3743,"date":"2022-04-01T13:34:48","date_gmt":"2022-04-01T17:34:48","guid":{"rendered":"https:\/\/a4pc.org\/?p=3743"},"modified":"2022-04-04T08:50:18","modified_gmt":"2022-04-04T12:50:18","slug":"apc-to-submit-amicus-brief-to-preserve-california-patients-access-to-glutathione-and-methylcobalamin","status":"publish","type":"post","link":"https:\/\/whizkid.com\/a4pc\/2022-04\/apc-to-submit-amicus-brief-to-preserve-california-patients-access-to-glutathione-and-methylcobalamin\/","title":{"rendered":"APC to submit amicus brief to preserve California patients\u2019 access to glutathione and methylcobalamin"},"content":{"rendered":"<p>Supported by its <a href=\"https:\/\/members.whizkid.com\/a4pc\/donate\/legal.html\">Legal Action Fund<\/a>, APC will file an <em>amicus<\/em> brief on behalf of La Vita Compounding Pharmacy in San Diego, which is facing enforcement action from the California Board of Pharmacy.<\/p>\n<p>At issue: California compounders&#8217; ability to compound glutathione and methylcobalamin.<\/p>\n<div style=\"width: 190px\" class=\"wp-caption alignright\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/files.constantcontact.com\/a9a22253501\/8f3a39d1-7802-433a-8cfd-8c449afabf07.jpg?rdr=true\" alt=\"\" width=\"180\" height=\"180\" \/><p class=\"wp-caption-text\"><em>Christine Givant, RPh<\/em><\/p><\/div>\n<p>Almost a year ago, the California BoP determined that it would not take enforcement action against pharmacies that compounded sterile preparations from bulk ingredients that are <em>on<\/em> the FDA\u2019s 503A Category 1 bulk substances list, but do <em>not<\/em> have USP\/NF drug monographs. Despite saying that, however, the board continued to initiate enforcement actions in those cases \u2014 including targeting APC member Christine Givant, RPh, of La Vita Compounding Pharmacy, who compounded glutathione and methylcobalamin.<\/p>\n<p>APC used its Legal Action Fund to retain attorneys Stephen Snow and Jennifer Bellis of Bendin Sumrall &amp; Ladner, LLC, to write the brief in support of La Vita and all other California-licensed pharmacies. The LAF is funded by an annual voluntary $50 dues-bill gift from renewing APC members. Our goal is to protect patient access to glutathione and methylcobalamin \u2014 and to prevent the board\u2019s unlawful prohibition against using these bulk substances to compound sterile drug products.<\/p>\n<p>&#8220;The California Board of Pharmacy is trying to impose an arbitrary restriction that is not supported by FDA regulations or California law,&#8221; said APC CEO Scott Brunner, CAE. &#8220;We\u2019re concerned not only about Christine and La Vita Pharmacy, but that if the California board is able to get away with this, other states will try to follow \u2014 and it\u2019s patients who will suffer.&#8221;<\/p>\n<p>(The California BoP strenuously objected to APC even being allowed to <em>submit<\/em> the brief, but the judge was not persuaded by the BoP\u2019s arguments and will allow it.)<\/p>\n<p>Read our <a href=\"https:\/\/whizkid.com\/a4pc\/files\/2022-03_ISSUE-BRIEF-Califonia-LaVita-Disciplinary-Action.pdf\">more-detailed issue brief for members on the La Vita case here<\/a>.<\/p>\n<p><a href=\"https:\/\/members.whizkid.com\/a4pc\/donate\/legal.html\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter\" src=\"https:\/\/members.whizkid.com\/a4pc\/userfiles\/uploads\/invest-legal.png\" alt=\"\" width=\"480\" height=\"96\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>At issue: California compounders&#8217; ability to compound glutathione and methylcobalamin.<br \/><span class=\"read-more\"><a target=\"_blank\" href=\"https:\/\/whizkid.com\/a4pc\/2022-04\/apc-to-submit-amicus-brief-to-preserve-california-patients-access-to-glutathione-and-methylcobalamin\/\"><\/a><\/span><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3743","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts\/3743","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/comments?post=3743"}],"version-history":[{"count":2,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts\/3743\/revisions"}],"predecessor-version":[{"id":3745,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/posts\/3743\/revisions\/3745"}],"wp:attachment":[{"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/media?parent=3743"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/categories?post=3743"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/whizkid.com\/a4pc\/wp-json\/wp\/v2\/tags?post=3743"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}